Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Postmenopausal Osteoporosis Clinical Trial

Official title:

A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091793
• Other study ID #: 20040132
• Status: Completed
• Phase: Phase 3
• First received: September 17, 2004
• Last updated: December 22, 2010
• Start date: August 2004
• Est. completion date: March 2009

Study information

• Verified date: December 2010
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 90 Years

Eligibility

Eligibility Criteria

• Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• AMG 162
60 mg/mL denosumab given day 1, month 6, month 12 and month 18
• Placebo
Placebo given at day 1, month 6, month 12 and month 18

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (2)

Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. doi: 10.1210/jc.2007-2814. Epub 2008 Apr 1. — View Citation

Engelke K, Libanati C, Liu Y, Wang H, Austin M, Fuerst T, Stampa B, Timm W, Genant HK. Quantitative computed tomography (QCT) of the forearm using general purpose spiral whole-body CT scanners: accuracy, precision and comparison with dual-energy X-ray abs — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.	24 Months	No
Secondary	Total Hip Bone Mineral Density Percent Change From Baseline at Month 24	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.	24 Months	No
Secondary	Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.	24 Months	No
Secondary	Trochanter Bone Mineral Density Percent Change From Baseline at Month 24	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.	24 months	No
Secondary	Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.	24 months	No
Secondary	Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.	24 months	No
Secondary	Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24	Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).	24 months	No
Secondary	Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24	Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).	24 months	No
Secondary	Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24	Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).	24 months	No

External Links

•   AmgenTrials clinical trials website